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Methotrexate Vial Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION.

METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use
Initial U.S. Approval: 1953

WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS

See full prescribing information for complete boxed warning.

  • Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. Use in non-neoplastic diseases is contraindicated during pregnancy. Advise females and males of reproductive potential to use effective contraception during and after treatment with Methotrexate Injection. (4, 5.1, 8.1, 8.3)
  • Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis. (4, 5.2).
  • Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis. Use only preservative-free Methotrexate Injection for treatment of neonates or low-birth weight infants, and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available. (2.1, 5.3)
  • Other serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, kidneys, liver, nervous system, gastrointestinal tract, lungs, and skin. Withhold or discontinue Methotrexate Injection as appropriate. (5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 5.10, 5.11)

RECENT MAJOR CHANGES

Boxed Warning3/2021
Indications and Usage (1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.10 )3/2021
Dosage and Administration (2.1 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 2.10, 2.11, 2.12)3/2021
Warnings and Precautions (5.1, 5.3, 5.5, 5.6, 5.7, 5.9, 5.13)3/2021

INDICATIONS AND USAGE

Methotrexate Injection is a folate analog metabolic inhibitor indicated for:

  • The following neoplastic diseases for the:
    • Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen (1.1)
    • Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia (1.2)
    • Treatment of adult and pediatric patients with non-Hodgkin lymphoma (1.3)
    • Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen (1.4)
    • Treatment of adults with breast cancer as part of a combination chemotherapy regimen (1.5)
    • Treatment of adults with squamous cell carcinoma of the head and neck as single-agent (1.6)
    • Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen (1.7)
  • Treatment of adults with rheumatoid arthritis (RA). (1.8)
  • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9)
  • Treatment of adults with severe psoriasis. (1.10)

DOSAGE AND ADMINISTRATION

  • Verify pregnancy status in females of reproductive potential before starting Methotrexate Injection. (2.1, 4, 5.1)
  • Neoplastic diseases: Refer to the prescribing information for disease specific dosing recommendations. Follow guidelines for high-dose regimens. (2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9)
  • RA: Recommended starting dosage of 7.5 mg once weekly intramuscularly; adjust dose to achieve an optimal response. (2.10)
  • pJIA: Recommended starting dosage of 10 mg/m2 once weekly subcutaneously or intramuscularly; adjust dose to achieve an optimal response. (2.11)
  • Psoriasis: Recommended dosage of 10 mg to 25 mg once weekly intramuscularly or intravenously; adjust dose to achieve optimal response. Once achieved, reduce to lowest possible dosage. (2.12)

DOSAGE FORMS AND STRENGTHS

Injection: (3)

  • With preservative (multiple-dose vials): 50 mg/2 mL (25 mg/mL)
  • Preservative-free (single-dose vials): 1 g/40 mL (25 mg/mL)

CONTRAINDICATIONS

  • History of severe hypersensitivity to methotrexate. (4)
  • Pregnancy: in patients with non-neoplastic diseases. (4)

WARNINGS AND PRECAUTIONS

  • Secondary malignancies can occur. (5.13)
  • Tumor lysis syndrome can occur in patients with rapidly growing tumors. (5.14)
  • Immunizations and Risks associated with Live Vaccines: Immunizations may be ineffective. Live vaccines are not recommended due to risk of disseminated infection. (5.15)
  • Infertility: Can cause impairment of fertility, oligospermia, and menstrual dysfunction. (5.16, 8.3)

ADVERSE REACTIONS

Common adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Refer to full prescribing information for drug interactions with Methotrexate Injection. (7)

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise not to breastfeed. (8.2)
  • Pediatric use: Intermediate-dose methotrexate can cause serious neurotoxicity in patients with acute lymphoblastic leukemia. (8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2021

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